Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT01881516
Eligibility Criteria:
Inclusion Criteria:
* Patients who are pathologically/cytologically diagnosed as NSCLC and received radiotherapy with or without chemotherapy, and the last radio- or chemo-therapy must be at least 30 days prior to initiation of experimental treatment;
* Participants who meet the diagnosis criteria of CRF（ICD-10 criteria);
* The first time to receive acupuncture treatment;
* The age is between 18 and 65 years old;
* Mean baseline fatigue as measured by the Brief Fatigue Inventory (BFI) must be four or above;
* ECOG performance status 0, 1 or 2.
* Patients must have adequate organ functions reflected by the laboratory criteria below: neutrophil counts ≥ 1.5×109 /L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 85 g/L, Serum creatinine \< 2.0 mg/dL, Bilirubin \< 1.5 mg/dL, ALT \< 3 x normal, albumin \>30g/L.
* Have not taken any hypnotic, melatonin, or antidepressants within 30 days;
* Willing to finish the whole observation period;
* With written consent form signed by themselves.
Exclusion Criteria:
* Participants in other clinical research;
* Can not be pathologically or cytologically diagnosed as NSCLC;
* ECOG 3\~4;
* Pregnant woman;
* \>65 or \<18 years old;
* Patients with evidence of any cognitive dysfunction that would limit their abilities to report fatigue;
* Patients who have received acupuncture ever before;
* Received surgery, immunotherapy or target therapy within one month before the recruition；
* Taking warfarin or heparin, a bleeding tendency exists;
* Infection, ulceration or hyperalgesia at or near the local acupoints' skin，or with active infections；
* There are cerebral vascular accident history or spinal cord injury history；
* Combination with other serious diseases or condition, including congestive heart failure, Unstable angina pectoris, myocardial infarction during the past six months, serious's arrhythmia, mental disorders, drug abuse, etc.;
* Patients with a life expectancy \< 3 months;
* Patients with a past history of therapy or scheduled visits non-compliance, as determined by their treating physician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01881516
Study Brief:
Protocol Section:
NCT01881516